UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study to examine the effect of Ramelteon on end of life delirium
Title of the study (Brief title)	Exploratory study to examine the effect of Ramelteon on end of life delirium
Region	Japan

Condition
Condition	Advanced cancer
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether Ramelteon has a preventive effect on end of life delirium.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of delirium in a week
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Ramelteon 8mg/day
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. In palliative care unit 2. Possible to take medicine orally 3. Cancer associated pain is well controlled 4. Life expectancy is shorter than 1 months 5. Written informed consent
Key exclusion criteria	1. Having regular use of antipsychotics, antidepressants, antimanics and anticonvulsants. 2. Dementia 3. Serious complications such as liver failure, respiratory insufficiency, heart failure, or renal failure 4. Alcoholism or psychiatric patients 5. Already diagnosed delirium 6. Symptomatic intracranial lesions
Target sample size	22

Research contact person
Name of lead principal investigator	Akira Inoue
Organization	Tohoku University School of Medicine
Division name	Department of Palliative Medicine
Address	2-1, Seiryocho, Aobaku, Sendai
TEL	022-717-7366
Email	akira.inoue.b2@tohoku.ac.jp

Public contact
Name of contact person	Yusuke Hiratsuka
Organization	Tohoku University School of Medicine
Division name	Department of Palliative Medicine
Address	2-1, Seiryocho, Aobaku, Sendai
TEL	022-717-7366
Homepage URL
Email	yusuke.hiratsuka.e6@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University School of Medicine, Department of Palliative Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東北大学病院（宮城県）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 23 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 06 Month 22 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 16 Day
Last modified on	2018 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031809